System and method for all-inside suture fixation for implant attachment and soft tissue repair

ABSTRACT

A system for repairing a meniscus includes a suture that includes a first anchor, a second anchor, and a flexible portion connecting the first anchor and the second anchor. The flexible portion includes a self-locking slide knot between the first anchor and the second anchor. The system also includes a needle having a longitudinal extending bore and an open end. The bore is configured to receive the first anchor and the second anchor. The system further includes a body portion operatively connected to the needle at a distal end of the body portion. The body portion has a lumen. The system also includes a pusher configured to rotate and slide within the lumen of the body portion and the longitudinal extending bore of the needle. The pusher has first and second stop surfaces, each of which is constructed and arranged to engage a proximal end of the body portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 11/501,235, filed Aug. 9, 2006 and entitled “SYSTEMAND METHOD FOR ALL-INSIDE SUTURE FIXATION FOR IMPLANT ATTACHMENT ANDSOFT TISSUE REPAIR,” the entire content of which is hereby incorporatedby reference, which is a continuation-in-part of U.S. patent applicationSer. No. 11/348,467, filed Feb. 7, 2006 and entitled “SYSTEM AND METHODFOR ALL-INSIDE SUTURE FIXATION FOR IMPLANT ATTACHMENT AND SOFT TISSUEREPAIR,” the entire content of which is hereby incorporated byreference, which claims the benefit of priority from U.S. ProvisionalPatent Application No. 60/650,131, filed Feb. 7, 2005 and entitled“SYSTEM AND METHOD FOR ALL-INSIDE SUTURE FIXATION FOR IMPLANT ATTACHMENTAND SOFT TISSUE REPAIR,” the entire content of which is herebyincorporated by reference.

BACKGROUND

Field of the Invention

The present invention relates generally to a system and method forattaching an implant during meniscal repair and for other soft tissuerepair. More particularly, the present invention relates to a system andmethod for an all-inside suture fixation device and method designed forthe placement of surgical anchors for the attachment of an implant tothe meniscus and for soft tissue repair. The present invention alsorelates to a system designed to reduce, or bring into closeapproximation, pieces of torn or damaged soft tissue to facilitatetissue repair and healing.

Description of Related Art

There are current procedures for surgical attachment of a soft tissueimplant in a joint, such as an autograft, allograft, or xenograft tissueor other compatible tissues and/or devices. Such implants may bebioresorbable and/or non-resorbable, synthetic and/or non-synthetic. Oneexample of a bioresorbable implant is the ReGen® CMI™, a collagen-basedmeniscus implant, the surgical attachment of which can involvetechniques that are difficult to master. There is a need therefore, fora fixation device to facilitate a faster, easier to use method forattaching an implant to a host tissue. Suture fixation devices, such asthe FAST-FIX™ and RAPIDLOC™, which were designed to repair tears inmeniscus tissue, have certain limitations in their delivery of anchorsto attach an implant to the meniscal rim in that they may causeunnecessary destruction to the implant and require additionalinstruments and steps that are not integral to the device itself. Theneedle used to pass the anchor through an implant and through themeniscal rim punctures the implant in a manner that may lead to tearingof the implant matrix. There is a need, therefore, for a dimensionallysmaller device that employs a smaller needle that delivers a lessdestructive anchor through an implant and the meniscus, thereby reducingthe size of the puncture hole in the implant and the potential fortearing the implant matrix.

There is a need, therefore, for a fixation device that includes anintegrated knot pusher to secure the delivered anchor, and optionally,also includes a suture cutter for use after one or more anchors havebeen secured. Techniques that require separate instruments for knotpushing and suture cutting are less efficient, and require greaterskill, time, and additional manipulation at the surgical site.

Prior art devices and methods for suture fixation of an implant to soiltissue within a joint typically tear the matrix of the implant duringneedle insertion and/or anchor delivery. There remains a need for adevice and method for fixing an implant to soft tissue that can insertanchors through the implant and host tissue with minimal destruction ofthe implant, in a well-controlled and easy manner. Also, there remains aneed for a device and method for fixing a collagen-based meniscusimplant to the host meniscal tissue, in a well-controlled and easymanner, whereby the needle and anchor insertion cause minimal to nodestruction of the collagen-based meniscus implant. Also, there remainsa need for a device and method for fixing a collagen-based meniscusimplant to the host meniscal tissue that puts adequate tension betweenthe anchors in a ell-controlled and easy manner.

BRIEF SUMMARY OF THE INVENTION

The fixation delivery system of the present invention is an integrateddesign for use with the multiple elements required for suture fixationwhen attaching a soft tissue implant to host tissue or when performingtissue repair procedures in general. The present system and methodachieves the deployment of anchors into soft tissue and knot pushingwith the use of a single instrument, and, optionally, may also providefor suture cutting within that single instrument. The hollow needleapplicator and anchors are of smaller dimensions than currentapplicators and anchors to minimize the damage to the implant duringneedle insertion and anchor deployment.

The fixation delivery system of the present invention is an integrateddesign for use with the multiple elements required fir suture fixationwhen attaching a soft tissue implant to host tissue or when performingtissue repair procedures in general. The present system and methodachieves the deployment of anchors into soft tissue and knot pushingwith the use of a single instrument, and, optionally, may also providefor suture cutting within that single instrument. The hollow needleapplicator and anchors are of smaller dimensions than currentapplicators and anchors to minimize the damage to the implant duringneedle insertion and anchor deployment.

In an embodiment of the invention, the applicator for deployment of theanchors includes a hollow needle or cannula having a longitudinalextending bore and an open end, into which a suture, which includes twosurgical anchors, is loaded. The first anchor and the second anchor areconnected via a flexible portion of the suture. The flexible portionincludes a self-locking slide knot located between the first anchor andthe second anchor. The needle is inserted into an incision already madein the patient's body, through the implant, and through the hostmeniscus to the outside rim of the meniscus, or through the soft tissuerequiring repair. Alternatively, the needle may penetrate directlythrough the patient's skin and into the joint capsule comprising theknee. The first anchor is ejected from the tip of the hollow needle bygripping the handle of the applicator and pulling the trigger, whichadvances a push rod within the hollow needle. The anchor is released,from the open end of the needle to seat firmly on the surface of thesoft tissue or rim of the meniscus (i.e., the meniscus rim). The needleis removed from the initial insertion site and inserted through theimplant and through the meniscus or host soft tissue a short distancefrom the initial insertion point, without removing the needle from thepatient's body. The second anchor is deployed by gripping the trigger ofthe applicator to advance the push rod a second time and release thesecond anchor. The needle is withdrawn or retracted from the secondinsertion site, thereby leaving two anchors positioned on the outsiderim of the meniscus. The push rod, or pusher, functions as a knot pusherand can be used to push a self-locking slide knot; located on theflexible portion between the first and second anchors, until the knot isflush with the implant. Also, the flexible portion may be tightened byhand until adequate tension is applied to hold the pair of anchorsfirmly in place. Excess length of the flexible portion/suture can be cutusing a cutter, which may be in the form of a suture cutting surface onthe applicator. Again, the system is designed so that the deployment ofthe anchors, the pushing of the self-locking slide knot, and theoptional cutting may all be completed without removing the needle fromthe patient's body.

In an embodiment, a system for repairing a meniscus is provided. Thesystem includes a suture that includes a first anchor, a second anchor,and a flexible portion connecting the first anchor and the secondanchor. The flexible portion includes a self-locking slide knot betweenthe first anchor and the second anchor. The system also includes aneedle having a longitudinal extending bore and an open end. The bore isconfigured to receive the first anchor and the second anchor. The systemfurther includes a pusher configured to be movable within the bore ofthe needle. The pusher is configured to (1) discharge the first anchorand the second anchor, and (2) push the self-locking slide knot afterthe discharge of the second anchor.

In embodiment, a method for repairing a meniscus is provided. The methodincludes providing a system for repairing a meniscus. The systemincludes a suture that includes a first anchor, a second anchor, and aflexible portion connecting the first anchor and the second anchor. Theflexible portion includes a self-locking slide knot between the firstanchor and the second anchor. The system also includes a needle having alongitudinal extending bore and an open end. The bore is configured toreceive the first anchor and the second anchor. The system furtherincludes a pusher configured to be movable within the bore of theneedle. The pusher is configured to (1) discharge the first anchor andthe second anchor, and (2) push the self-locking slide knot after thedischarge of the second anchor. The method also includes providing animplant, passing the needle of the system through the implant and themeniscus at a first location to deliver the first anchor to an oppositeside of the meniscus, retracting the needle from the meniscus and theimplant, passing the needle of the system through the implant and themeniscus at a second location to deliver the second anchor to theopposite side of the meniscus, and pushing the self-locking slide knotto a surface of the implant.

In an embodiment, a method for repairing a meniscus in a body with animplant and a suture is provided. The method includes inserting a needlethrough the implant and the meniscus at a first location, delivering afirst anchor of the suture to an opposite side of the meniscus,retracting the needle from the meniscus and the implant, inserting theneedle through the implant and the meniscus at a second location, anddelivering a second anchor of the suture to the opposite side of themeniscus. The second anchor is connected to the first anchor with aflexible portion of the suture. The method also includes pushing aself-locking slide knot located along the flexible portion between thefirst anchor and the second anchor to a surface of the implant. Thedelivering of the second anchor and the pushing the self-locking knotare completed without removing the needle from the body.

In an embodiment, a method for repairing a tear in a meniscus in a bodywith a suture is provided. The method includes inserting a needlethrough the meniscus at a first location, delivering a first anchor ofthe suture to an opposite side of the meniscus, retracting the needlefrom the meniscus, inserting the needle through the meniscus at a secondlocation on an opposite side of the tear as the first location, anddelivering a second anchor of the suture to the opposite side of themeniscus. The second anchor is connected to the first anchor with aflexible portion of the suture. The method further includes pushing aself-locking slide knot located along the flexible portion between thefirst anchor and the second anchor to a surface of the meniscus. Thedelivering of the second anchor and the pushing of the self-locking knotare completed without removing the needle from the body.

In an embodiment, an applicator for delivering a suture to an implantfor repairing a meniscus in a body is provided. The suture includes afirst anchor, a second anchor, and a flexible portion that connects thefirst anchor to the second anchor. The applicator includes a needlehaving a longitudinal bore. The longitudinal bore is configured toreceive the first anchor and the second anchor. The applicator alsoincludes a pusher for pushing the first anchor and the second anchor outof the longitudinal bore of the needle. The pusher is configured toreceive the flexible portion therein and expose a portion of theflexible portion of the suture. The applicator also includes a cuttingsurface configured to cut the suture.

In an embodiment, a system for repairing a meniscus is provided. Thesystem includes a suture that includes a first anchor, a second anchor,and a flexible portion connecting the first anchor and the secondanchor. The flexible portion includes a self-locking slide knot betweenthe first anchor and the second anchor. The system also includes aneedle having a longitudinal extending bore and an open end. The bore isconfigured to receive the first anchor and the second anchor. The systemalso includes a body portion operatively connected to the needle at adistal end of the body portion. The body portion has a lumen. The systemfurther includes a pusher configured to rotate and slide within thelumen of the body portion and the longitudinal extending bore of theneedle. The pusher has a first stop surface and a second stop surface.The first stop surface of the pusher is constructed and arranged toengage a proximal end of the body portion after the first anchor hasbeen discharged from the needle by the pusher to prevent the pusher fromdischarging the second anchor. The second stop surface of the pusher isconstructed and arranged to engage the proximal end of the body portionafter the second anchor has been discharged from the needle by thepusher.

In embodiment, a method for repairing a meniscus in a body with animplant and a suture is provided. The method includes inserting a needlethrough the implant and the meniscus at a first location, pushing apusher in a first orientation to a first position relative to the needleto deliver a first anchor of the suture to an opposite side of themeniscus, and retracting the needle from the meniscus and the implant.The method also includes inserting the needle through the implant andthe meniscus at a second location, rotating the pusher from the firstorientation to a second orientation relative to the needle, and pushingthe pusher in the second orientation to a second position relative tothe needle to deliver a second anchor of the suture to the opposite sideof the meniscus. The second anchor is connected to the first anchor witha flexible portion of the suture. The method further includes retractingthe needle from the meniscus and the implant, pushing a self-lockingslide knot located along the flexible portion between the first anchorand the second anchor to a surface of the implant with the pusher, androtating the pusher from the second orientation relative to the needleto cut the flexible portion of the suture at a location adjacent theself-locking slide knot.

In an embodiment, an applicator for delivering a suture to an implantfor repairing a meniscus in a body is provided. The suture includes afirst anchor, a second anchor, and a flexible portion that connects thefirst anchor to the second anchor. The applicator includes a needlehaving a longitudinal extending bore and an open end. The bore isconfigured to receive the first anchor and the second anchor. Theapplicator also includes a body portion operatively connected to theneedle at a distal end of the body portion. The body portion has alumen. The applicator further includes a pusher configured to slide androtate within the lumen of the body portion and the longitudinal bore ofthe needle. The pusher has a first stop surface and a second stopsurface. The first stop surface of the pusher is constructed andarranged to engage a proximal end of the body portion after the firstanchor has been discharged from the needle by the pusher to prevent thepusher from discharging the second anchor. The second stop surface ofthe pusher is constructed and arranged to engage the proximal end of thebody portion after the second anchor has been discharged from the needleby the pusher.

With minor alterations, this anchor delivery system device may be usedin other procedures for soft-tissue repair, and most preferably forarthroscopic procedures. Examples include, but are not limited to use inreparative procedures for soft tissue damage in joints, securing tissuegrafts, and attaching resorbable implants and synthetic scaffolds tohost tissue.

Other aspects, features, and advantages of the present invention willbecome apparent from the following detailed description, theaccompanying drawings, and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Features of the invention are shown in the drawings, in which likereference numerals designate like elements. The drawings form part ofthis original disclosure, in which:

FIG. 1 is a side view of an embodiment of a system for all-inside suturefixation for implant attachment and soft tissue repair of the presentinvention;

FIG. 2 is a top view of an embodiment of a needle of the system of FIG.1;

FIG. 3 is a side view of the needle of FIG. 2;

FIG. 4 is a cross-sectional view taken along line 4-4 in FIG. 2;

FIG. 5 is a side view of another embodiment of the needle for the systemof FIG. 1;

FIG. 6 is a top view of the needle of FIG. 5;

FIG. 7 is a cross-sectional view taken along line 7-7 in FIG. 6;

FIG. 8 is a side view of a pusher of the system of FIG. 1;

FIG. 9 is a top view of an anchor of a suture of the system of FIG. 1;

FIG. 10 is an end view of the anchor of FIG. 9;

FIG. 11 is a side view of the anchor of FIG. 9;

FIG. 12 is a top view of another embodiment of an anchor of the suturefor the system of FIG. 1;

FIG. 13 is an end view of the anchor of FIG. 12;

FIG. 14 is a side view of the anchor of FIG. 12;

FIG. 15 is a view of an anchor threaded onto a flexible portion of thesuture of the system of FIG. 1;

FIG. 16 is a view of the anchor and the flexible portion of FIG. 15 witha loop and a self-locking slide knot formed in the flexible portion;

FIG. 17 is a view of the anchor and the flexible portion of FIG. 16 witha second anchor positioned on the flexible portion;

FIG. 18 is a partial view of the second anchor and the flexible portionof FIG. 17;

FIG. 19 is a partial view of the second anchor and the flexible portionof FIG. 17 with a needle threaded on the flexible portion;

FIG. 20 is a partial view of the needle threaded on the flexible portionand passing through the center of the suture at the second anchor;

FIG. 21 is a partial view of the needle passing through the center ofthe suture at the second anchor a second time;

FIG. 22 is a view of the anchor with a knot securing it to the flexibleportion;

FIG. 23 is a partial view of the flexible portion and the second anchorat one end thereof;

FIG. 24 is a perspective view of a meniscus with an implant positionedon the meniscus;

FIG. 25 is a view of the implant after it has been stapled to themeniscus;

FIG. 26 is a view of the suture of the system of FIG. 1;

FIG. 27 is a top view of the needle with the pusher extended therefrom;

FIG. 28 is a side view of the suture being threaded into the pusher andthe needle;

FIG. 29 is a side view of the suture further being threaded into thepusher and the needle;

FIG. 30 is a top view of the needle with the suture loaded therein;

FIG. 31 is a side view of the needle of FIG. 30;

FIG. 32 is a top view of the needle of the system of FIG. 1 piercing theimplant and meniscus of FIG. 25 at a first location;

FIG. 33 is a top view of the needle of FIG. 32 after the first anchorhas been ejected from the needle with the pusher;

FIG. 34 is a perspective view of the needle of FIG. 32 after it has beenpulled back through the meniscus and implant;

FIG. 35 is a top view of the needle of FIG. 32 piercing the implant andmeniscus of FIG. 25 at a second location;

FIG. 36 is a top view of the needle of FIG. 35 after the second anchorhas been ejected from the needle with the pusher;

FIG. 37 is a top view of the needle of FIG. 35 after is has been pulledback through the meniscus and implant;

FIG. 38 is a top view of the needle of FIG. 37 with the pusher extendedout of the needle;

FIG. 39 is a top view of the needle of FIG. 38 with the pusher pushingthe knot against the implant;

FIG. 40 is a top view of the needle of FIG. 39 after it has been pulledback following knot pushing and suture tensioning;

FIG. 41 is a side view of the needle of FIG. 40 with the suture exposedto the needle cutting surface;

FIG. 42 is a side view of another embodiment of the needle of FIG. 40with the suture exposed to a cutting surface on a cutting sheath;

FIG. 43 is a top view of the repaired meniscus with the suture tightlyin place;

FIG. 44 is a side view of another embodiment of a system for all-insidesuture fixation for implant attachment and soft tissue repair of thepresent invention;

FIG. 45 is a proximal end view of a body portion of the system of FIG.44;

FIG. 46 is a side view of an embodiment of a pusher of the system ofFIG. 44;

FIG. 47 is a cross-sectional view of the pusher taken along line 47-47in FIG. 46;

FIG. 48A is a side view of a proximal end of the pusher of FIG. 46 in afirst position relative to the body portion;

FIG. 48B is the proximal end view of the body portion with a portion ofthe pusher in the first position of FIG. 48A;

FIG. 48C is a side view of a needle of the system of FIG. 44 and adistal end of the pusher, with the pusher in the first position of FIG.48A;

FIG. 49A is a side view of the proximal end of the pusher of FIG. 46 ina second position relative to the body portion;

FIG. 49B is the proximal end view of the body portion with a portion ofthe pusher in the second position FIG. 49A;

FIG. 49C is a side view of the needle and the distal end of the pusher,with the pusher in the second position of FIG. 49A;

FIG. 50A is a side view of the proximal end of the pusher of FIG. 46 ina third position relative to the body portion;

FIG. 50B is the proximal end view of the body portion with a portion ofthe pusher in the third position of FIG. 50A;

FIG. 50C is a side view of the needle and the distal end of the pusher,with the pusher in the third position of FIG. 50A;

FIG. 51A is a side view of the proximal end of the pusher of FIG. 46 ina fourth position relative to the body portion;

FIG. 51B is the proximal end view of the body portion with a portion ofthe pusher in the fourth position of FIG. 51A;

FIG. 51C is a side view of the needle and the distal end of the pusher,with the pusher in the fourth position of FIG. 51A;

FIG. 52A is a side view of the proximal end of the pusher of FIG. 46 ina fifth position relative to the body portion;

FIG. 52B is the proximal end view of the body portion with a portion ofthe pusher in the fifth position of FIG. 52A;

FIG. 52C is a side view of the needle and the distal end of the pusher,with the pusher in the fifth position of FIG. 52A;

FIG. 53A is a side view of the proximal end of the pusher of FIG. 46 ina sixth position relative to the body portion;

FIG. 53B is the proximal end view of the body portion with a portion ofthe pusher in the sixth position of FIG. 53A; and

FIG. 53C is a side view of the needle and the distal end of the pusher,with the pusher in the sixth position of FIG. 53A.

DETAILED DESCRIPTION OF THE INVENTION

A system 1 for repairing a meniscus according to embodiments of thepresent invention is illustrated in FIG. 1. The system 1 includes anapplicator 10 that is constructed and arranged to deploy a suture 12 tothe meniscus. The suture 12 generally includes a flexible portion 58 anda pair of anchors 60, 70. The suture 12 will be discussed in greaterdetail below.

The applicator 10 includes a body portion 14 that defines a handle 16that is configured to be grasped by the user. The body portion 14 of theapplicator 10 receives a cannula 18 that extends from the body portion14 in a direction that is away from the handle 16. The body portion 14and cannula 18 may be constructed and arranged like those described andshown in U.S. Pat. No. 5,928,252, entitled Device and Method for Drivinga Needle and Meniscal Repair, which is incorporated herein by referencein its entirety. Because the inner workings of the body portion 14 arenot related to the present invention, they are not described in detailherein.

The applicator 10 also includes a needle 20 that is connected to adistal end of the cannula 18 Of course, the needle 20 may be consideredto be a part of the cannula 18 itself The needle 20 will be described ingreater detail below. The applicator 10 also includes a pusher 23 thatincludes a hollow rod 24 that extends through the body portion 14, thecannula 18, and is slidingly received by the needle 20. A knob 26 isattached to one end of the rod 24 and a spacer 28 with a tab 29 isdisposed between the knob 26 and a proximal end 15 of the body portion14 so that the movement of the knob 26 relative to the body portion 14and, hence, movement of the rod 24 relative to the needle 20, may belimited to prevent premature ejection of one of the anchors 60 prior tothe placement of the other anchor 70, as described in further detailbelow. A trigger 30 is connected to and extends from the body portion14, as shown in FIG. 1. The trigger 30 is configured to manually controlthe advancement of the rod 24 within the cannula 18. A side lever 32 isconnected to the body portion so as to be pivotable thereon. Operationof the side lever 32 will be discussed in greater detail below.

As shown in FIG. 1, a depth penetration limiter 21 is placed over thedistal end of the cannula 18 so as to partially cover the needle 20. Thelimiter 21 provides the user with a visualization of the depth of theneedle 20 in the tissue to avoid neurovascular injury. An outer sheath22 is placed over the limiter 21 to aid in the insertion of the cannula18 into the incision already created in the patient. The outer sheath 22is preferably designed to partially surround the limiter 21 so that theuser may still see at least a portion of the limiter 21 when the needle20 is being inserted into the incision. The outer sheath 22 is removedby the user once the cannula 18 has been inserted into the incisionsite.

One embodiment of a needle 20 a that may be used as the needle 20 inFIG. 1 is shown in FIGS. 2-4. As shown, the needle 20 a includes asleeve 34 a that is attached to the cannula 18 at a proximal end. Theneedle 20 a also includes a distal end 36 a that is connected to thesleeve 34 a and is constructed and arranged to be inserted into ameniscus or a tissue. The distal end 36 a is substantially straight andincludes a point 38 a for piercing the meniscus or tissue and a slot 40a, which allows for the flexible portion 58 of the suture 12 to extendout of the needle 20 a. As shown in the Figures, the distal end 36 a ofthe needle 20 a also includes a cutting surface 37 a that is constructedand arranged to cut excess suture 12, which will be described in greaterdetail below.

As shown in FIGS. 2-4, a cutting sheath 35 a that at least partiallysurrounds the distal end 36 a may also be provided. In the illustratedembodiment, the cutting sheath 35 a completely surrounds thecircumference of the distal end 36 a. In other embodiments, the cuttingsheath 35 a may only partially surround the distal end 36 a. The cuttingSheath 35 a is configured to be slidable relative to the distal end 36 aso that it may be moved longitudinally along the distal end 36 a towardthe point 38 a, and then moved back again toward the sleeve 34 a. Thecutting sheath 35 a may include a tab that extends outward from theneedle 20 a so that the user my manipulate the cutting sheath 35 a viathe tab. As shown, the cutting sheath 35 a includes at least one cuttingsurface 33 a that is constructed and arranged to cut excess suture 12,which will be described in a detail below.

As shown in FIG. 4, the distal end 36 a is configured to hold the pairof anchors 60, 70 of the suture 12. The needle 20 a may include a dimple39 a located near the point 38 a to assist in seating the anchors 60, 70prior to deployment of the anchors 60, 70 from the needle 20 a, as willbe described in greater detail below. The needle 20 a is preferablymanufactured from stainless steel, and is sized to withstand insertionthrough the implant and the meniscus substantially without bending orbuckling.

Another embodiment of a needle 20 b that may be used as the needle 20 inthe applicator 10 is shown in FIGS. 5-7. As shown, the needle 20 bincludes a sleeve 34 b that is attached to the cannula 18 at a proximalend. The needle 20 b also includes a distal end 36 b that is connectedto the sleeve 34 b and is constructed and arranged to be inserted into ameniscus or a tissue. The distal end 36 b is curved such that it extendsat an angle a relative to the sleeve 34 b. The angle a may be about15-45°, and is preferably about 30°. The distal end 36 b also includes apoint 38 b for piercing the meniscus or tissue and a slot 40 b, whichallows for portions of the suture 12 to extend out of the needle 20 b.The distal end 36 b of the needle 20 b also includes at least onecutting surface 37 b that is constructed and arranged to cut excesssuture 12.

As shown in FIGS. 5-7, a cutting sheath 35 b that at least partiallysurrounds the distal end 36 b may also be provided. In the illustratedembodiment, the cutting sheath 35 b completely surrounds thecircumference of the distal end 36 b. In other embodiments, the cuttingsheath 35 b may only partially surrounds the distal end 36 b. Thecutting sheath 35 b is configured to be slidable relative to the distalend 36 b so that it may be moved longitudinally along the distal end 36b toward the point 38 b, and back again to the sleeve 34 b. The cuttingsheath 35 b may include a tab that extends outward from the needle 20 bso that the user my manipulate the cutting sheath 35 b via the tab. Asshown, the cutting sheath 35 b includes a cutting surface 33 b that isconstructed and arranged to cut excess suture 12.

As shown in FIG. 7, the distal end 36 b is also configured to hold thepair of anchors 60, 70. The needle 20 b may also include a dimple 39 blocated near the point 38 b to assist in seating the anchors 60, 70prior to deployment. Like the needle 20 a of FIGS. 2-4, the needle 20 bis preferably manufactured from stainless steel, and is sized towithstand insertion through the implant and the meniscus substantiallywithout bending or budding.

An embodiment of the pusher 23 is shown in greater detail in FIG. 8. Therod 24 is hollow and is configured to receive the flexible portion 58 ofthe suture 12 that extends away from the needle 20. The knob 26 includesa hole for receiving the rod 24, so that the flexible portion 58 of thesuture 12 may extend through the knob 26 as well. A distal portion ofthe rod 24 includes a pair of slots 42 that are configured to allow theflexible portion 58 of the suture 12 to be threaded out of the rod 24via one slot 42 (the distal slot) and back into the rod 24 via the otherslot 42 (the proximal slot), as represented by an exposed portion 44 ofthe flexible portion 58 of the suture 12. This threading of the suture12 properly aligns the exposed portion 44 relative to the rod 24 tofacilitate the cutting of the suture 12, which will be described infurther detail below. As shown in FIG. 7, the rod 24 may be flexible sothat it may be used with the embodiment of the needle 20 b describedabove.

FIGS. 9-11 illustrated an embodiment of an anchor 46 that may be used asthe anchors 60, 70 of the suture 12. As shown, the anchor 46 includes atab 48 that extends upward from a body 50. The body 50 has opposing ends51 that are substantially perpendicular to a longitudinal axis LA of theanchor 46. A hole 52 that is centered on the longitudinal axis LAextends through the body 50 and the tab 48 where the body 50 and tab 48are connected. Otherwise, the body 50 includes a hollowed outhalf-cylinder 53 at portions where the tab 48 is not connected. Theanchor 46 is preferably made out of a bioabsorbable polymer, such aspoly(L-lactide).

Another embodiment of an anchor 54 for use in the suture 12 of thesystem 1 is shown in FIGS. 12-14. As shown, the anchor 54 is a solid rodwith a pair of holes 56 that extend substantially perpendicularlythrough the longitudinal axis of the rod. The holes 56 are sized toreceive a flexible portion of the suture 12. A recessed channel 57 islocated between the holes 56 to seat the flexible portion 58 of thesuture 12. Like the anchor 46, the anchor 54 is preferably made out of abioabsorbable polymer, such as poly(L-lactide).

In another embodiment of an anchor that may be used as one or both ofthe anchors 60, 70 of the suture 12, the anchor may include at least onebarb that is formed from or connected to a main body portion of theanchor. The barb may be constructed and arranged to be biased to anorientation in which a free end of the barb extends away from the body,yet is oriented such that the free end is near the body when suitablepressure is applied to the barb. The use of such an anchor with thesystem 1 will be described in greater detail below.

Unless otherwise indicated herein, further discussions of the anchors60, 70 will be for the anchor 46 illustrated in FIGS. 9-11, although itis understood that the anchor 54 of FIGS. 12-14 may be used with slightmodifications to the language used to describe the assembly of thesuture 12. Such modifications would be readily appreciated by one ofskill in the art and are therefore not described herein.

FIGS. 15-23 show the various stages of an embodiment of assembling thesuture 12 of the system 1 of FIG. 1. FIG. 15 shows the flexible portion58 of the suture 12 with one anchor 60 threaded thereon. FIG. 16 shows aloop 62 and a knot 64 that closes the loop 62, with the anchor 60 beinglocated within the loop 62. The knot 64 is preferably a self-lockingslide knot. Methods for tying a self-locking slide knot are describedin, for example, “A New Clinch Knot,” Weston, P. V., Obstetrics &Gynecology, Vol. 78, pp. 144-47 (1991); “Physical Properties of SelfLocking and Conventional Surgical Knots,” Israelsson, L. A., et al.,European Journal of Surgery, Vol. 160, No. 6-7, pp. 323-27 (1994);“Nicky's Knot—A New Slip Knot for Arthroscopic Surgery,” De Beer, J. F.,et al., Arthroscopy: The Journal of Arthroscopic and Relate Surgery,Vol. 14, No 1, pp. 109-110 (1998); “The Giant Knot: A New One-WaySelf-Locking Secured Arthroscopic Slip Knot,” Fleega, B. A., et al.,Arthroscopy: The Journal of Arthroscopic and Relate Surgery, Vol. 15, No4, pp. 451-52 (1999); “Arthroscopic Knot Tying Techniques,” Nottage, W.M., et al., Arthroscopy: The Journal of Arthroscopic and Relate Surgery,Vol. 15, No 5, pp. 515-521 (1999); “The SMC Knot—A New Slip Knot WithLocking Mechanism,” Kiln, S., et al., Arthroscopy: The Journal ofArthroscopic and Relate Surgery, Vol. 16, No 5, pp. 563-65 (2000);“Technical Note: A ‘New’ Arthroscopic Sliding Knot,” Field, M. H., etal., Orthopedic Clinics of North America, Vol. 32, No. 3, pp. 525-26(2001); “Arthroscopic Knot Tying,” Kim, S., et al., Techniques inShoulder & Elbow Surgery, Vol. 4, No. 2, pp. 35-43 (2003); “The PC Knot:A Secure and Satisfying Arthroscopic Slip Knot,” Pallia, C. S.,Arthroscopy: The Journal of Arthroscopic and Relate Surgery, Vol. 19, No5, pp. 558-560 (2003); and “The Tuckahoe Knot: A Secure Locking SlipKnot,” Wiley, W. B., et al., Arthroscopy: The Journal of Arthroscopicand Relate Surgery, Vol. 20, No 5, pp. 556-59 (2004), all of which areincorporated herein by reference in their entireties.

Once the self-locking slide knot 64 has been tied, another anchor 70 isslid onto the flexible portion 58 until it is located approximately 7 mmfrom the knot 64, as shown in FIG. 17 (note that the Figures are notnecessarily drawn to scale). This distance is only meant to be anexample and is not intended to be limiting in any way. The flexibleportion 58 of the suture 12 is tied off with one hitch knot 74 on theanchor 70, as shown in FIG. 18.

Next, as shown in FIG. 19, a needle 72 is threaded with the remainder ofthe flexible portion 58. The end of the flexible portion 58 with theneedle 72 is passed through the center of the suture of the hitch knottwice to hold the hitch knot 74 in place, as shown in FIGS. 20 and 21.As shown in FIG. 22, the excess flexible portion 58 is cut, leavingapproximately 2 mm as a tail. Finally, as shown in FIG. 23, the tip ofthe flexible portion 58 may be melted to prevent fraying of the suture12. An assembled suture 12 before it is loaded into the applicator 10 isshown in FIG. 26.

FIG. 24 shows a damaged meniscus 80 having a rim 81, and an implant 82positioned adjacent the damaged part of the meniscus 80. The implant 82may be any type of implant 82 suitable for such meniscus repair.Preferably, the implant 82 includes collagen. In an embodiment, theimplant 82 includes the CMI, a collagen-based meniscus implant. Theimplant 82 illustrated in the Figures has already been cut to theappropriate size. Both ends of the implant 82 may be temporarily stapledor sutured using conventional means to hold the implant 82 in placewhile it is being secured to the meniscus 80. FIG. 25 shows a pair ofstaples 84, or sutures, holding the implant 82 in place.

To load the suture 12 into the applicator 10, the cannula 18, with theneedle 20 a attached, is inserted into the body portion 14 of theapplicator 10. In this embodiment, the needle 20 a of FIGS. 24 is shown.However, it is understood that the needle 20 b may also be used in thesame way. The illustrated and described embodiments are not intended tobe limiting in any way. While holding down the side lever 32 with afinger or a thumb, the rod 24 of the pusher 23 is inserted by the userinto the proximal end 15 of the body portion 14 until the end of the rod24 extends past the point 38 a of the needle 20 a with the slots 42facing upward, as shown in FIG. 27.

Next, as shown in FIG. 28, an end 59 of the suture 12 that is oppositethe anchor 70 is threaded though the rod 24 of the pusher 23 at thedistal end 36 a of the needle 20 a. The end 59 of the suture 12 is lacedthrough the distal end of the rod 24, pulled out of the rod 24 at thedistal slot 42, threaded back into the rod 24 at the proximal slot 42,thereby leaving the exposed portion 44 outside of the rod 24. The end 59of the suture 12 may extend several inches outside the pusher 23 beyondthe proximal end 15 of the body portion 14 of the applicator 10 so thatthe user may grasp the suture 12 during the implant attachmentprocedure, which will be described below. Once the suture 12 has beenloaded into the applicator 10, the user then presses the side lever 32and retracts the pusher 23 back into the needle 20 a, as shown in FIG.29, to locate the slots 42 and the exposed portion 44 of the suture 12before the proximal end of the needle slot 40 a, as shown in FIG. 30.The anchor 60 is inserted into the distal end 36 a of the needle 20 a,and is followed by the anchor 70, as shown in FIGS. 30 and 31. The end59 of the flexible portion 58 that extends out of the pusher 23 at theproximal end 15 of the body portion 14 of the applicator 10 may bepulled so that the knot 64 is generally located on a side of the anchor60 that is opposite the other anchor 70, as shown in FIG. 31 After theanchors 60, 70 are loaded into the cannula 18, a portion of the flexibleportion 58 may extend outside of the cannula 18 via the slot 40 a of theneedle 20 a, as shown in FIGS. 30 and 31. In this arrangement, thepulling of the trigger 30 causes the anchor 70, the anchor 60, and theknot 64 to be deployed in that order.

Once the system 1 is assembled, the user places the spacer 28 betweenthe knob 26 and the proximal end 15 of the body portion 14 so that theadvancement of the anchor 60 will be limited until the placement of theanchor 70 is complete. The user then inserts the depth penetrationlimiter 21 and the outer sheath 22 over the distal end of the cannula 18so as to cover the needle 20 during insertion of the needle 20 into theincision site. Once the needle 20 has been inserted into the incisionsite, the outer sheath 22 may be removed from the cannula 18. Of course,the use of the spacer 28, the outer sheath 22, and the depth penetrationlimiter 21 should be considered optional. The illustrated embodiment isnot intended to be limiting in any way.

The user may then advance the anchors 60, 70 until the anchor 70 islocated near the point 38 a of the needle 20 a, without extending out ofthe needle 20 a. The dimple 39 a may be used to assist with theplacement of the anchor 70. In embodiments where the dimple 39 a isused, the user should feel a slight resistance to the advancement of theanchor 70, which signals the user to stop advancing the pusher 23. Ofcourse, the use of the dimple 39 a should be considered to be optional.The illustrated embodiment is not intended to be limiting in any way.

While griping the handle 16 and the trigger 30 on the applicator 10, theuser inserts the needle 20 a into a patient at an incision site so thatthe needle 20 a may then be inserted through the implant 82 and throughthe meniscus 80 at a first location 86, preferably near the center ofthe implant 82, to a side opposite the insertion site, as shown in FIG.32. The user should be sure that the hitch knot 74 on the anchor 70 haspassed through the meniscus 80, as shown in FIG. 32. In an embodiment,the user then advances the pusher 23 via the trigger 30 until the anchor70 is pushed outside the needle 20 a, as shown in FIG. 33. The usershould be careful to not advance the pusher 23 further to avoid thepremature deployment of the anchor 60. The use of the spacer 28 assistsin preventing the premature deployment of the anchor 60. In addition to,or in lieu of the spacer 23, the dimple 39 a that is located near thepoint 38 a of the needle 20 a may also be used to provide the user withtactile feedback that the anchor 60 has been advanced to its properpre-deployment position.

As shown in FIG. 34, the user then retracts the needle 20 a slowly fromthe meniscus 80 and the implant 82, leaving the anchor 70 behind on theopposite side of the meniscus 80. The anchor 60 will remain inside theneedle 20 a. If the user hasn't already done so, the user next advancesthe anchor 60 until the anchor 60 is located near the point 38 a of theneedle 20 a. Again for embodiments that include the dimple 39 a, thedimple 39 a may be used to guide the user to correctly position theanchor 60.

While gripping the handle 16 and the trigger 30 on the applicator 10,the user inserts the needle 20 a though the implant 82 and through themeniscus 80 at a second location 88, which is preferably near the firstlocation 86, until the center of the anchor 60 is outside the oppositeside of the meniscus 80, as shown in FIG. 35. If the user hasn't alreadydone so, the user next removes the spacer 28 from the rod 24 by graspingthe tab 29 and pulling the spacer 28 away from the rod 24. The user thenadvances the pusher 3 until the anchor 60 is pushed outside the needle20 a, as shown in FIG. 36. The user then retracts the needle 20 a,thereby leaving the anchor 60 on the opposite side of the meniscus 80,as shown in FIG. 37.

Having deployed both anchors 60, 70, the user may then advance thepusher 23 via the trigger 30 so that the rod 24 extends approximately 1cm beyond the point 38 a of the needle 20 a, as shown in FIG. 38. Whilegripping the handle 16 and the trigger 30 of the applicator 10, the userthen holds the tip of the rod 24 against the knot 64 and pushes the knot64 to the surface of the implant 82, being careful not to push the knot64 through the implant 82. The user continues to grip the handle 16 andthe trigger 30 while gently pulling on the end 59 of the flexibleportion 58 of the suture 12 at the proximal end 15 of the body portion14 of the applicator 10 until slack in the suture 12 is taken up, andthe anchors 60, 70 sit flat against the meniscus 80, as shown in FIGS.39 and 40.

With the knot 64 now secured, the user may extend the rod 24 of thepusher 23 out of the needle 20 a approximately 1 cm. The user may thenrotate the pusher 23 up to approximately 180°, or until the slots 42 andthe exposed portion 44 of the suture 12 are positioned to come intocontact with the cutting surface 37 a when the pusher 23 is pulled backtoward the proximal end 15 of the body portion 14 of the applicator 10,as shown in FIG. 41. Holding the end 59 of the flexible portion 58 thatextends out of the proximal end 15, the user may shear the exposedportion 44 of the suture 12 against the cutting surface 37 a by slidingthe pusher 23 longitudinally against the cutting surface 37 a, as shownin FIG. 41, thereby leaving a short tail 67 near the knot 64, as shownin FIG. 43. The pusher 23 may have to be moved back and forth againstthe cutting surface 37 a before the suture 12 is fully cut.

In another embodiment, after the knot 64 is secured, while holding theend 59 of the flexible portion 58 that extends out of the proximal end15, the user may shear the exposed portion 44 of the suture 12 againstthe cutting surface 33 a by sliding the cutting sheath 35 a along thedistal end 36 a and toward the point 38 a of the needle 20 a, as shownin FIG. 42, thereby leaving a short tail 67 near the knot 64, as shownin FIG. 43. The cutting sheath 35 a may have to be moved back and forthalong the distal end of the needle 20 a before the suture 12 is fullycut.

The aforementioned system 1 and method provide au all-inside suturefixation to the implant and meniscus, because the needle 20 a of theapplicator 10 has not been removed from the patient's body between thedeployment of the anchor 70, the pushing of the knot 64, and the cuttingof the excess flexible portion 58 of the suture 12. This may bebeneficial to the patient because it may reduce the time the applicator10 is in the patient's body, and allows for a single, small entry pointof the needle 20 a, at the incision, into the patient's body.

The user may then repeat the steps shown in FIGS. 32-43 for anyremaining sutures 12 that are needed to complete the fixation of theimplant 82 to the meniscus 80. Generally, it may take three or moresutures 12 to secure the implant 82.

Of course, in alternative embodiments, the user may remove the bodyportion 14 of the applicator 10 and pusher 23 from the cannula 18, andtrim the excess flexible portion 58 of the suture 12 with scissors, orsome other cutting device. The illustrated embodiments are not intendedto be limiting in any way.

Also, in alternative embodiments, one or both of the anchors 60, 70 maybe the anchor described above that includes one or more barbs. Thisallows the user to advance the pusher 23 via the trigger 30 only until adistal end of the anchor is located adjacent the point of the needle 20in an orientation in which the barb is no longer engaged by the wall ofthe needle 20. When the anchor is in this position, the wall of theneedle 20 is no longer exerting pressure on the barb, thereby allowingthe barb to be biased outward and away from the body of the anchor. Thebarb may then be used to engage the anchor with the meniscus 80 so thatwhen the user pulls the needle 20 back through the meniscus 80 and theimplant 82, the entirety of the anchor will pull out of the needle 20without further advancement of the pusher 23.

It is also contemplated that the needle 20 may be designed such that thetab 48 on the anchor 46 may be used to engage the anchor 46 with themeniscus 80 before the anchor 46 exits the needle 20. This allows theentirety of the anchor 46 to be pulled out of the needle 20 when theneedle 20 is pulled back through the meniscus 80, rather than pushingthe entirety of the anchor 46 out of the needle 20 with the pusher 23,as described in the embodiments above.

Although the above-described procedure was in the context of attachingan implant to a meniscus with needle penetration of the implant and themeniscus in a substantially horizontal stitch, a substantially similarprocedure may be used for the placement of other types of stitches, suchas vertical and oblique, as would be appreciated by one of skill in theart. The illustrated and described embodiments should not be consideredto be limiting in any way.

In addition, although the above-described procedure was in the contextof attaching an implant to a meniscus, a substantially similar proceduremay be used to repair soft tissue, as would be appreciated by one ofskill in the art. The illustrated and described embodiments should notbe considered to be limiting y way. For example, to repair a tear in themeniscus 80 with the suture 12, the needle 20 may be inserted throughthe meniscus 80 a first location near the tear. The first anchor 70 ofthe suture 12 may then be delivered to an opposite side of the meniscus80, and the needle 20 retracted from the meniscus 80, without pullingout of the body. The needle may then be inserted through the meniscus 80at a second location on an opposite side of the tear as the firstlocation. The second anchor 60 of the suture 12 may then be delivered tothe opposite side of the meniscus 80. Once the second anchor 60 is inthe proper position, the user may then push the knot 64 to a surface ofthe meniscus 80 to tighten the suture. The excess of the flexibleportion 58 of the suture 12 may then be cut with any of the cuttingmethods described above.

In another embodiment, illustrated in FIGS. 44-52C, a system 100 forrepairing a meniscus is provided. The system 100 includes an applicator110 that is constructed and arranged to deploy the suture 12, whichincludes the flexible portion 58 and the two anchors 60, 70,as describedabove, to the meniscus. In this embodiment, the applicator 110 includesa body portion 114 that is configured to be grasped by the user. Asshown in FIGS. 44 and 45, the body portion 114 includes a pair ofextensions 116 at a proximal end 115 of the body portion 114. Each ofthe extensions 116 is constructed and arranged to engage a finger of theuser such that the body portion 114 is may be held in between thefingers in a similar way that a syringe is typically held.

As illustrated in FIG. 44, the body portion 114 of the applicator 110receives a cannula 118 that extends from a distal end 113 of the bodyportion 114 in a direction that is away from the proximal end 115. Thecannula 118 may be constructed and arranged like the cannula 18described and illustrated above, and in U.S. Pat. No. 5,928,252, whichis hereby incorporated by reference in its entirety, and may beconnected to the body portion 114 in a similar manner.

The applicator 110 also includes a needle 120 that has a cutting surface121 at a distal end thereof. The needle 120 is connected to a distal endof the cannula 118 so that it is operatively connected to the distal end113 of the body portion 114. Of course, the needle 120 may be consideredto be a part of the cannula 118 itself. The needle 120 may be of thesame design as the needle 20 a discussed above. As such, details of theneedle 120 will not will be described in further detail. Instead,reference should be made to the needle previously described andillustrated.

The applicator 110 also includes a pusher 123. The pusher 123 includes arod 124 (shown in FIG. 46) that extends through a central lumen 112 ofthe body portion 114, a central bore (not shown) of the cannula 118, andis slidingly received by the needle 120. A knob 126 is attached to oneend of the rod 124 and is configured to be grasped by the user so thatthe user may manipulate the rod 124, as described in further detailbelow. As shown in FIG. 46, the rod 124 includes proximal end 125 and adistal end 127, which has a smaller diameter than the diameter ofproximal end 125, as illustrated. The distal end 127 is configured toinclude a pair of slots 142 that are similar to the slots 42 discussedabove. A central bore 122 extends through the rod 124 and the knob 126so that the flexible portion 58 of the suture 12 may be threaded throughthe slots 142, through the rod 124, and through the knob 126, as Shownin FIG. 46.

As illustrated in FIG. 46, the pusher 123 includes a first projection128 that projects from the rod 124 and defines a first stop surface 129on one side thereof. The first projection 128 may be configured as asquare or rectangular tab, or may be in the shape of a cylinder. Theillustrated embodiment is not intended to be limiting in any way. Theknob 126 of the pusher 123 includes a stopper portion 130 that isconnected to the rod 124 and defines a second stop surface 131. Thepusher 123 also includes a second projection 132 that projects from therod 124 and defines a third stop surface 133 on one side thereof. Thesecond projection 130 is axially spaced from the first projection 128and is axially located between the first projection 128 and the distalend 127 of the rod 124.

As shown in FIG. 47, the second projection 130 is also radially spacedfrom the first projection 128. The radially spacing is defined by angleβ, and in the illustrated embodiment, the angle β is about 90°. It iscontemplated that the angle β may be in the range of about 10° to about370°, as will be appreciated in the discussion below. The illustratedembodiment is not intended to be limiting in any way.

As shown in FIG. 45, the body portion 114 defines an outer surface 134at its proximal end that is configured to engage the stop surfaces 129,131, 133 described above as the pusher 123 is moved to differentpositions relative o the body portion 114 and needle 120. The bodyportion 114 also includes an opening 36, shown in the Figures to beshaped as a keyhole, that is axially connected to the central lumen 112and is constructed and arranged to receive the first projection 128 andthe second projection 130 of the pusher 123, as discussed in furtherdetail below. The arrangement of the opening 136 in the proximal end 115of the body portion 114 is such that the pusher 123 should be in theproper orientation relative to the body portion 114 in order for thepusher 123 to move toward the needle 120 in an axial direction. Once thefirst projection 128 or the second projection 130 has passed through theopening, the respective projection 128, 130 is then located within thecentral lumen 112 of the body portion 114. The central lumen 112 issized to allow the projections 1.28, 130 to rotate with the rod 124about a central axis. However, when one of the projections 128, 130 ispositioned within the opening 136, the rod 124 will be prevented fromrotating.

FIGS. 48A-53C illustrate portions of the system 100 during differentstages of repairing a meniscus or other soft tissue. As shown in FIGS.48A-C, the pusher 123 is disposed in a first orientation and first axialposition relative to the body portion 114 and the needle 120. In thisorientation and position, the third stop surface 133 is engaged with theouter surface 134 of the body portion 114 such that pressure applied tothe knob 126 toward the body portion 114 will not cause the pusher 123to move in an axial direction. This allows the first anchor 70 to staywithin the needle 120, as shown in FIG. 48C, even if pressure is appliedto the pusher 123 via the knob 126. This may allow the user to applypressure to the applicator 110 via the knob 126 as the needle 120 isinitially inserted through the implant 82 and meniscus 80, as describedabove. For example, the user may hold the body portion 114 and engagethe extensions 116 with two fingers, while applying pressure to the knob126 with a thumb, like a syringe.

Once the needle 120 is in the proper location for the discharge of thefirst anchor 70, the user may rotate the pusher 123, via the knob 126,to a second orientation, which is 90° from the first orientation, asshown in FIGS. 49A-C. This orientation aligns the second projection 132of the pusher 123 with the opening 136 of the body portion 114, as shownin FIG. 49B. Because the pusher 123 has not yet been moved axially, thefirst anchor 70 is still located in the needle 120, as shown in FIG.49C.

The user may then apply pressure to the pusher 123 in an axial directionvia the knob 126 until the first surface 129 of the first projection 128engages the outer surface 134 of the body portion 114, as shown in FIG.50A. At this position, the second projection 132 has passed all the waythrough the opening 136 of the body portion 114 such that is in thecentral lumen 112. As shown in FIG. 50C, the first anchor 70 has beendischarged by the pusher 123 out of the needle 120. Other aspects of thedischarge of the anchor 70 are discussed above and shown in FIG. 33.

As discussed above and shown in FIGS. 34 and 35 with reference to theneedle 20 a, the user may then pull the needle 120 in a similar mannerso that it clears the meniscus 80 and the implant 82, and then insertthe needle through the implant 82 and the meniscus 80 at a secondlocation. Once the distal end of the needle 120 is in the location wherethe second anchor 60 should be discharged, the user may then rotate thepusher 123 to a third orientation, as shown in FIGS. 51A-C, which is 90°from the second orientation, and 180° from the first orientation. Atthis orientation, the first protrusion 128 is aligned with the opening136, and the second anchor 60 is still located within the needle 120.

The user may then apply pressure to the pusher 123 via the knob 123until the second stop surface 131 of the stopper 130 engages the outersurface 134 of the body portion 114, as shown in FIGS. 52A-B. Asillustrated, in this position, the first projection 128 has passed allof the way through the opening 136 and is in the central lumen 112 ofthe body portion 114. As shown in FIG. 52C, the second anchor 60 hasbeen discharged from the needle 120 by the pusher 123. Other aspects ofthe discharge of the second anchor 60 are discussed above and shown inFIG. 36. As discussed above and shown in FIGS. 37-40, the knot 64 of thesuture 12 may then be pushed against the implant 82, although in thisembodiment, the distal end 127 of the rod 124 of the pusher 123 is usedto push the knot 64 rather than the rod 24 shown in FIGS. 37-40. Oncethe knot 64 has been tightened and any slack is taken out of theflexible portion 58 of the suture 12, the pusher 123 may be rotated outof the third orientation, as shown in FIGS. 52A-C so as to shear theflexible portion 58 of the suture 12 against the cutting surface 121 ofthe needle 120. Once the flexible portion 58 has been cut, theapplicator 110 may be pulled out of the body. The applicator 110 maythen be disposed of, or, if desired, may be cleaned, sterilized, andused again.

The foregoing disclosure of embodiments of the present invention hasbeen presented for purposes of illustration and description. It is notintended to be exhaustive or to limit the invention to the precise formsdisclosed. Many variations and modifications of the embodimentsdescribed herein will be apparent to one of ordinary skill in the art inlight of the above disclosure. The scope of the invention is to bedefined only by the claims appended hereto, and by their equivalents.

Further, in describing representative embodiments of the presentinvention, the specification may have presented the method and/orprocess of the present invention as a particular sequence of steps.However, to the extent that the method or process does not rely on theparticular order of steps set forth herein, the method or process shouldnot be limited to the particular sequence of steps described. Forexample, any number of sutures may be prepared ahead of time. Inaddition, the advancement of the anchors within the cannula may occurbefore or after needle insertion. In addition, the delivery of thesecond anchor may not require that the needle be fully withdrawn; forexample when two anchors are to be delivered through a single insertionsite. As one of ordinary skill in the art would appreciate, othersequences of steps may be possible. Therefore, the particular order ofthe steps set forth herein should not be construed as limitations on theclaims. In addition, the claims directed to the method and/or process ofthe present invention should not be limited to the performance of theirsteps in the order written, and one skilled in the art can readilyappreciate that the sequences may be varied and still remain within thespirit and scope of the present invention.

1.-28. (canceled)
 29. A medical instrument, comprising: a body portionhaving a proximal handle portion including an opening, a distal cannulaextending from the handle portion, the distal cannula extending distallyto a tip having a cutting surface, and a lumen extending through thehandle portion and distal cannula; a pushrod positioned through thelumen and is slidingly received by the tip of the distal cannula and isrotatable relative to the body portion, the pushrod including a firststop surface positioned along the length of the pushrod, wherein, in afirst position of the pushrod, the first stop surface contacts the bodyportion to prevent distal movement of the pushrod through the bodyportion, and in a second position of the pushrod, the first stop surfacecan pass freely through the opening of the body portion to allow distalmovement of the pushrod through the body portion, such that, in thefirst position, the first stop surface is radially spaced from theopening of the body portion, and in the second position, the first stopsurface is radially aligned with the opening.
 30. The instrument ofclaim 29, wherein the handle portion includes at least one extension forengagement by a user.
 31. The instrument of claim 29, wherein thepushrod further comprises a proximal handle.
 32. The instrument of claim31, wherein the first stop surface is spaced distally from the handle.33. The instrument of claim 29, wherein the distal movement of thepushrod through the body portion is defined to a predetermined distance.34. The instrument of claim 29, wherein an anchor is positioned withinthe cannula distal to the pushrod, such that with the pushrod in thefirst position, the anchor remains within the cannula, and with thepushrod in the second position, the distal movement of the pushrodexpels the anchor from the tip of the distal cannula.
 35. The instrumentof claim 34, wherein the distal cannula further comprises a dimplepositioned within the lumen of the distal cannula.
 36. The implant ofclaim 35, wherein the dimple is positioned adjacent to the tip of thedistal cannula and provides a user with tactile feedback as to theposition of the anchor.
 37. A medical instrument, comprising: a bodyportion having a proximal handle portion, a distal cannula extendingfrom the handle portion, the distal cannula extending distally to a tiphaving a cutting surface, and a lumen extending through the handleportion and distal cannula; a pushrod positioned through the lumen andis slidingly received by the tip of the distal cannula; and a firststop, a second stop, and a third stop, each stop formed between asurface of the pushrod and a surface of the body portion, wherein withthe pushrod in a first position the first stop prevents distal movementof the pushrod relative to the body portion, and with the pushrod in asecond position, the pushrod can move distally relative to the bodyportion until the second stop, and with the pushrod in a third positionthe pushrod can move distally relative to the body portion until thethird stop.
 38. The instrument of claim 37, wherein the third stop isspaced axially from the second stop, and the second stop is spacedaxially from the first stop such that, at each successive stop, thepushrod is positioned more distally within the lumen.
 39. The instrumentof claim 37, wherein the pushrod is rotatable relative to the bodyportion.
 40. The instrument of claim 37, wherein an anchor is positionedwithin the cannula distal to the pushrod, such that with the pushrod inthe first position, the anchor remains within the cannula, and with thepushrod in the second position, the distal movement of the pushrodexpels the anchor from the tip of the distal cannula.
 41. The instrumentof claim 40, wherein the distal cannula further comprises a dimplepositioned within the lumen of the distal cannula.
 42. The instrument ofclaim 41, wherein the dimple is positioned adjacent to the tip of thedistal cannula and provides a user with tactile feedback as to theposition of the anchor.
 43. A method of positioning a first anchor and asecond anchor relative to tissue to repair the tissue, the methodcomprising the steps of: obtaining an instrument comprising: a bodyportion having a proximal handle portion, a distal cannula extendingfrom the handle portion, the distal cannula extending distally to a tiphaving a cutting surface, and a lumen extending through the handleportion and distal cannula; a pushrod positioned through the lumen andis slidingly received by the tip of the distal cannula; and a firststop, a second stop, and a third stop, each stop formed between asurface of the pushrod and a surface of the body portion, wherein withthe pushrod in a first position the first stop prevents distal movementof the pushrod relative to the body portion, and with the pushrod in asecond position, the pushrod can move distally relative to the bodyportion until the second stop, and with the pushrod in a third positionthe pushrod can move distally relative to the body portion until thethird stop, wherein the first anchor and second anchor are positionedwithin the cannula distal to the pushrod and the first anchor ispositioned distal to the second anchor; passing the tip through thetissue at a first location such that at least a portion of the cannulais positioned within the tissue and the tip of the cannula is outside ofthe tissue; actuating the pushrod from the first position towards thesecond position to expel the first anchor from the tip; removing theinstrument from the tissue; passing the tip through the tissue at asecond location such that at least a portion of the cannula ispositioned within the tissue and the tip of the cannula is outside ofthe tissue; actuating the pushrod from the second position towards thethird position to expel the second anchor from the tip; removing theinstrument from the tissue; tensioning a length of suture associatedwith the first and second anchor.
 44. The method of claim 43, whereinthe actuating steps each comprise rotating the pushrod relative to thebody portion to allow the pushrod to advance distally relative to thebody portion from the first position towards the second position andfrom the second position towards the third position, respectively. 45.The method of claim 44, wherein the distal cannula further comprises adimple positioned within the lumen of the distal cannula and adjacent tothe tip of the distal cannula such that during each actuating step, thedimple provides a resistance against each successive anchor as a tactilefeedback to a user as to the positioning of the particular anchor to beexpelled.
 46. The method of claim 43, wherein, during each of thepassing steps, with the instrument at the first stop or second stop, auser can apply a distal force on the pushrod to pass the tip through thetissue at the first location or second location, respectively.